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USP DI Vol. II - FLUOROURACIL (Systemic)

FLUOROURACIL (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Adrucil

In Canada?

  • Adrucil

Generic name product may be available in the U.S. and Canada.

Another commonly used name is 5-FU.


Category

  • Antineoplastic

Description

Fluorouracil (flure-oh-YOOR-a-sill) belongs to the group of medicinesknown as antimetabolites. It is used to treat cancer of the colon, rectum,breast, stomach, and pancreas. It may also be used to treat other kinds ofcancer, as determined by your doctor.

Fluorouracil interferes with the growth of cancer cells, which are eventuallydestroyed. Since the growth of normal body cells may also be affected by fluorouracil,other effects will also occur. Some of these may be serious and must be reportedto your doctor. Other effects, like hair loss, may not be serious but maycause concern. Some effects may not occur for months or years after the medicineis used.

Before you begin treatment with fluorouracil, you and your doctor shouldtalk about the good this medicine will do as well as the risks of using it.

Fluorouracil is to be administered only by or under the immediate supervisionof your doctor. It is available in the following dosage form:

    Parenteral
  • Injection (U.S. and Canada)


Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For fluorouracil, thefollowing should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to fluorouracil.

Pregnancy?Tell your doctor if you are pregnant or if you intendto have children. There is a chance that this medicine may cause birth defectsif either the male or female is receiving it at the time of conception orif it is taken during pregnancy. Fluorouracil has been reported to cause birthdefects in mice given doses slightly higher than the human dose. Also, therehas been one case of a baby born with several birth defects after the motherreceived fluorouracil. In addition, many cancer medicines may cause sterility.Although sterility has been reported with this medicine, it is usually onlytemporary; the possibility should be kept in mind.

Be sure that you have discussed this with your doctor before receivingthis medicine. It is best to use some kind of birth control while you arereceiving fluorouracil. Tell your doctor right away if you think you havebecome pregnant while receiving fluorouracil.

Breast-feeding?Tell your doctor if you are breast-feeding or ifyou intend to breast-feed during treatment with this medicine. It is not knownwhether fluorouracil passes into breast milk. However, because fluorouracilmay cause serious side effects, breast-feeding is generally not recommendedwhile you are receiving it.

Children?Although there is no specific information comparinguse of fluorouracil in children with use in other age groups, it is not expectedto cause different side effects or problems in children than it does in adults.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. Although there is no specific informationcomparing use of fluorouracil in the elderly with use in other age groups,it is not expected to cause different side effects or problems in older peoplethan it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are receivingfluorouracil, it is especially important that your health care professionalknow if you are taking any of the following:

  • Amphotericin B by injection (e.g., Fungizone) or
  • Antithyroid agents (medicine for overactive thyroid) or
  • Azathioprine (e.g., Imuran) or
  • Chloramphenicol (e.g., Chloromycetin) or
  • Colchicine or
  • Flucytosine (e.g., Ancobon) or
  • Ganciclovir (e.g., Cytovene) or
  • Interferon (e.g., Intron A, Roferon-A) or
  • Plicamycin (e.g., Mithracin) or
  • Zidovudine (e.g., AZT, Retrovir) or
  • Warfarin (e.g. Coumadin)
  • If you have ever been treated with radiation or cancer medicines?Fluorouracilmay increase the effects of these medicines or radiation on the blood

Other medical problems?The presence of other medicalproblems may affect the use of fluorouracil. Make sure you tell your doctorif you have any other medical problems, especially:

  • Chickenpox (including recent exposure) or
  • Herpes zoster (shingles)?Risk of severe disease affecting otherparts of the body
  • Infection?Fluorouracil can decrease your body's ability tofight infection
  • Kidney disease or
  • Liver disease?Effects of fluorouracil may be increased becauseof slower removal from the body

Proper Use of This Medicine

This medicineis sometimes given together with certain other medicines. If you are usinga combination of medicines, it is important that you receive each one at theproper time. If you are taking some of these medicines by mouth, ask yourhealth care professional to help you plan a way to remember to take them atthe right times.

Fluorouracil often causes nausea and vomiting. However, it is very importantthat you continue to receive the medicine, even if your stomach is upset.Ask your health care professional for ways to lessen these effects.

Dosing?The dosing of fluorouracil will be differentfor different patients. The dose that is used may depend on a number of things,including what the medicine is being used for, the patient's weight, and whetheror not other medicines are also being taken. If you arereceiving fluorouracil at home, follow your doctor's orders or the directionson the label. If you have any questions about the proper dose of fluorouracil,ask your doctor.


Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check forunwanted effects.

While you are being treated with fluorouracil, and after you stop treatmentwith it, do not have any immunizations (vaccinations)without your doctor's approval. Fluorouracil may lower your body'sresistance and there is a chance you might get the infection the immunizationis meant to prevent. In addition, other persons living in your household shouldnot take oral polio vaccine since there is a chance they could pass the poliovirus on to you. Also, avoid persons who have taken oral polio vaccine withinthe last several months. Do not get close to them and do not stay in the sameroom with them for very long. If you cannot take these precautions, you shouldconsider wearing a protective face mask that covers the nose and mouth.

Fluorouracil can temporarily lower the number of white blood cells in yourblood, increasing the chance of getting an infection. It can also lower thenumber of platelets, which are necessary for proper blood clotting. If thisoccurs, there are certain precautions you can take, especially when your bloodcount is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Checkwith your doctor immediately if you think you are getting an infectionor if you get a fever or chills, cough or hoarseness, lower back or side pain,or painful or difficult urination.
  • Check with your doctor immediately ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine or stools; or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick.Your medical doctor, dentist, or nurse may recommend other ways to clean yourteeth and gums. Check with your medical doctor before having any dental workdone.
  • Do not touch your eyes or the inside of your nose unless you havejust washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects suchas a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injurycould occur.


Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects.Although not all of these side effects may occur, if they do occur they mayneed medical attention.

Also, because of the way these medicines act on the body, there is a chancethat they might cause other unwanted effects that may not occur until monthsor years after the medicine is used. These delayed effects may include certaintypes of cancer, such as leukemia. Discuss these possible effects with yourdoctor.

    Check with your doctoror nurse immediately if any of the following side effects occur:

      More common

        Diarrhea; heartburn; sores in mouth and on lips

      Less common

        Black, tarry stools; cough or hoarseness,accompanied by fever or chills; fever or chills; lower back or side pain, accompanied by fever or chills; nausea and vomiting (severe); painfulor difficult urination, accompanied by fever or chills; stomach cramps

      Rare

        Blood in urine or stools; pinpoint redspots on skin; unusual bleeding or bruising

    Check withyour health care professional as soon as possible if any of the followingside effects occur:

      Rare

        Chest pain; cough; shortness of breath; tingling of hands and feet,followed by pain, redness, and swelling; troublewith balance

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. Also, your health care professionalmay be able to tell you about ways to prevent or reduce some of these sideeffects. Check with your health care professional if any of the followingside effects continue or are bothersome or if you have any questions aboutthem:

    More common

      Loss of appetite; nausea and vomiting; skin rash and itching; weakness

    Less common

      Dry or cracked skin

This medicine often causes a temporary loss of hair. After treatment withfluorouracil has ended, normal hair growth should return.

After you stop receiving fluorouracil, it maystill produce some side effects that need attention. During this period oftime, check with your doctor or nurse immediatelyif you notice any of the following:

Black, tarry stools; blood in urineor stools; cough or hoarseness, accompanied by feveror chills; fever or chills; lower back or side pain, accompanied by fever or chills; painful or difficult urination, accompanied by fever or chills; pinpoint red spots on skin; unusualbleeding or bruising

Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your health care professional.


Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although these uses are not included in productlabeling, fluorouracil is used in certain patients with the following medicalconditions:

  • Cancer of the outside layer of the adrenal gland
  • Cancer of the anus
  • Cancer of the bladder
  • Cancer of the cervix
  • Cancer of the endometrium
  • Cancer of the ovaries
  • Cancer of the esophagus
  • Cancer of the head and neck
  • Cancer of the penis
  • Cancer of the liver
  • Cancer of the prostate
  • Cancer of the skin
  • Cancer of the vulva
  • Carcinoid tumors
  • Hepatoblastoma (a certain type of liver cancer that occurs in children)
  • Glaucoma, during and after certain surgery (trabeculectomy)

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for these uses.


Revised: 05/04/2001